MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Contamination with Body Fluid (2317); High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrioventricular nodal re-entrant tachycardia (avnrt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster inc, (bwi) product analysis lab observed an electrode was lifted on the returned device.Initially, it was reported that when coming ablation, there was a steady rise in impedance noticed on the carto 3 system.The caller reported that they then removed the smarttouch sf catheter from the body, and it was noticed that there was char present on the tip of the smarttouch sf catheter.The physician cleaned the tip of the smarttouch sf catheter and continued the procedure.The caller then reported that the physician was concerned that the force reading was inaccurate.The smarttouch sf catheter was replaced, and the issue resolved.The caller noted that the smartablate generator was set to power control mode, at 35 watts.The procedure continued.No adverse patient consequences were reported.The char was assessed as not mdr reportable.Char is a physical phenomenon of radiofrequency (rf) energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.The high impedance was assessed as not mdr reportable.Since the user-defined cut-off was not exceeded, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.The force issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found that an electrode was observed lifted.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 02-mar-2023.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on 30-jan-2023.The device evaluation was completed on 02-mar-2023.Visual inspection, screening, temperature, impedance, patency, cool flow pump, and pressure gage tests of the returned device were performed following bwi procedures.Visual inspection was performed, and char residues were observed on the tip, occluding the irrigation holes in addition, an electrode was observed lifted.However, the root cause of the electrode bent could be related to the handling since there are control inspection points in the process to avoid these issues.The screening, temperature, and impedance tests were performed, and the device was found working correctly.Force values and the vector were observed within specifications.No force, temperature, or impedance issues were observed.A cool flow pump, pressure gage, and patency tests were performed, and the device failed.High-pressure values were observed when the device was undeflected and deflected.Partially occlusion was observed.This issue is related due to the char observed on the tip, occluding the holes.A deep analysis was performed.The tip was inspected, a microscope examination was performed, and it was observed the char laid on the tip; an electrode previously observed was severely bent, exposing internal components.The issue reported by the customer was confirmed.Product failure is multifactorial.The instructions for use contain the following guideline: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is maintained.Using tip temperature to guide ablation could result in deeper lesions and an increased risk for collateral damage.A manufacturing record evaluation was performed for the finished device number: 30934869l, and no internal action was found during the review.Biosense webster's quality process ensures all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16638577
• MDR Text Key: 312865583
• Report Number: 2029046-2023-00673
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30934869L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F; UNK_CARTO 3